At-Home Transvaginal Pelvic Ultrasonography and Image Quality in Premenopausal Women: A Nonrandomized Clinical Trial.

内容摘要

Transvaginal pelvic imaging is an integral and sensitive aspect of gynecologic care that individuals find both invasive and burdensome. At-home transvaginal imaging provides an opportunity to navigate these barriers to care. To evaluate the use of at-home transvaginal ultrasonography for gynecologic assessment, as measured by diagnostic imaging quality and participant satisfaction, in a broad sampling of women aged 22 to 50 years. Prospective, interventional, single group nonrandomized clinical trial with blinded review of collected images from premenopausal women aged 22 to 50 from Florida, Massachusetts, Maryland, Maine, Minnesota, New Hampshire, Texas, Utah, Virginia, Vermont, and Washington, DC. Images were gathered between July 2022 and July 2023, and data were analyzed from April to September 2025. At-home pelvic ultrasonography guided by verbal communication with a fully trained remote sonographer who had real-time access to study images. Cine clips were used to capture standard views of the uterus, ovaries, cervix, and posterior cul-de-sac. Primary outcomes were image quality and participant net promoter score (NPS), reflecting participants' likelihood of recommending the procedure, with higher scores indicating greater likelihood. Secondary outcomes included minor pain or discomfort, sonographer reported experience and/or pain, and all other adverse events. A total of 265 participants (mean [SD] age, 32 [6.7] years; mean [SD] body mass index, 27.0 [5.6]) enrolled in the trial, and 263 ultrasonographic scans were completed. Image quality showed that 253 at-home ultrasonographic scans (96.2%) met diagnostic quality while 10 (3.8%) did not. NPS was significantly higher with use of the at-home ultrasonography (59) compared with in-clinic scans (24), with an adjusted difference of 33.7 (95% CI, 23.3-44.0; z&#x2009;=&#x2009;6.35; P&#x2009;<&#x2009;.001). No adverse events were reported. This nonrandomized clinical trial of at-home pelvic ultrasonography in premenopausal women demonstrated that broad use of at-home gynecologic ultrasonography technology is feasible, safe, and preferred by participants and sonographers compared with in-clinic ultrasonography. At-home ultrasonographic imaging presented an innovative and clinically acceptable alternative to in-clinic care, providing opportunities for improved access to and decreased burden of gynecologic and reproductive care. ClinicalTrials.gov NCT05443698.